Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)

Bipolar Depression Clinical Trial

Official title:

A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Fixed-Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00868699
• Other study ID #: D1050236
• Secondary ID: EUDRACT No. 2008
• Status: Completed
• Phase: Phase 3
• First received: March 23, 2009
• Last updated: March 31, 2014
• Start date: April 2009
• Est. completion date: February 2012

Study information

• Verified date: March 2014
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)India: Drugs Controller General of IndiaRomania: National Medicines AgencyRussia: Ministry of Health of the Russian FederationSouth Africa: Medicines Control CouncilUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression

Recruitment information / eligibility

• Status: Completed
• Enrollment: 505
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subject is diagnosed with bipolar I disorder, most resent episode depressed

• Subject must have a lifetime history of at least one bipolar manic or mixed episode

Exclusion Criteria:

• History of nonresponse to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode

• Subject has been hospitalized for a manic or mixed episode within 60 days prior to randomization

• Imminent risk of suicide or injury to self, others, or property

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Depression
• Depression
• Depressive Disorder

Intervention

Drug:
• lurasidone
lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
• lurasidone
lurasidone 20 mg/day for Days 1-7
• Placebo
Placebo Comparator

Locations

Country	Name	City	State
Czech Republic	Psychiatricka ambulance	Brno - mesto
Czech Republic	Medical Services Prague s.r.o.	Kolejni 429-5	Praha
Czech Republic	BIALBI s.r.o., Psychiatricke Oddeleni	Litomerice
Czech Republic	Clintrial, s.r.o.	Praha
France	Hopital Caremeau, Service de Psychiatrie A	Nimes Cedex
France	Zans Ritter, Marcel	Orvault
India	Mental Illness Treatment Rehabilitationi Foundation	Ahmedabad	Gujarat
India	Samvedna Hospitals	Ahmedabad	Gujarat
India	Seth K M School of P G Medicine & Research	Ahmedabad	Gujarat
India	Spandana Nursing Home	Bangalore	Karna
India	R.K. Yadav Memorial Mental Health & De-Addiction Hospital	Jaipur	Rajasthan
India	Manobal Med. Research Centre	Lucknow	Uttar Prad
India	Sujata Birla Hospital & Research Centre	Nashik	Mahara
India	S V Medical College	Tirupati	Andh Prad
India	Vijayawada Institute of Mental Health and Neurosciences, Psychiatry	Vijaywada	Andh Prad
Romania	Spitalul Clinic de Urgenta Militar Central	Bucdresti
Romania	Spitalul Clinic de Psihaiatrie Prof. Dr. Alexandru Obregia	Bucuresti
Romania	Spitalul Clinic Judetean de Urgenta Cluj	Cluj-Napoca
Romania	Spitalul Clinic de Neuropsihiatrie Craiova	Craiova
Romania	Spitalul Clinic de Neurologie si Psihiatrie Oradea	Oradea
Russian Federation	Bekhterev Scientific Research Psychoneurological Institute	St. Petersburg
Russian Federation	City Psychiatric Hospital #2 of St. Nikolay Chudotvorets	St. Petersburg
Russian Federation	Psychoneurology Dispensary #4	St. Petersburg
South Africa	Cape Trial Centre	Cape Town, W. Cape
South Africa	Paarl Medical Centre	Paarl, W. Cape
South Africa	Clinika	Port Elizabeth, E. Cape
South Africa	Dey Clinic	Pretoria, Gauteng
South Africa	Vereeniging Medi-Clinic	Vereeniging, Free State
Ukraine	Chair of Psychiatry and Medical Psychology	Donetsk
Ukraine	Reg. Psychiatric Hospital	Odessa
Ukraine	Reg Cl.Ps.H.n.a.O.F. Malstev, Fem.Ac. Gen. Ps.D.5B	Poltava
Ukraine	CRI Cl.Psych.Hosp. #1, Fem. Psych. Dept. #2, Male I	Simferopol
Ukraine	Reg. Psych. Hosp.n.a.O.Yuschenko, Dept #21	Vinnitsia
United States	Albuquerque Neuroscience Inc., 101 Hospital Loop, NE, Suite 209	Albuquerque	New Mexico
United States	University of Colorado	Aurora	Colorado
United States	FutureSearch Clinical Trials, LLC.,4200 Marathon Blvd.,Suite 200	Austin	Texas
United States	Sheppard Pratt Health System,6501 North Charles Street	Baltimore	Maryland
United States	Florida Clinical Research Center, LLC,3914 State Road 64 East	Bradenton	Florida
United States	Neurobehavioral Research, Inc.	Cedarhurst	New York
United States	MetroHealth System	Cleveland	Ohio
United States	Mood Disorders Program-UHCMC	Cleveland	Ohio
United States	Synergy Escondido,710 East Grand Ave.	Escondido	California
United States	Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3	Garden Grove	California
United States	Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340	Lake Charles	Louisiana
United States	Florida Clinical Research Center, LLC,2300 Maitland Center Parkway,Suite 230	Maitland	Florida
United States	American Medical Research Inc.,1200 Harger Road Suite 415	Oak Brook	Illinois
United States	Excell Research, Inc,3998 Vista Way,Suite 100	Oceanside	California
United States	University of California at Irvine Medical Center	Orange	California
United States	CRI Worldwide, LLC	Philadelphia	Pennsylvania
United States	California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road	Pico Rivera	California
United States	Richard H. Weisler., M.D., P.A., & Associates,700 Spring Forest Road,Suite 125	Raleigh	North Carolina
United States	Finger Lakes Clinical Research	Rochester	New York
United States	California Neuropsychopharmacology Clinical Research Institute, LLC,466 26th Street,6th Floor	San Diego	California
United States	Depression and Anxiety Disorders Research Institute	Tampa	Florida
United States	Janus Center for Psychiatric Research,5601 Corporate Way,Suite 103	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Countries where clinical trial is conducted

United States,  Czech Republic,  France,  India,  Romania,  Russian Federation,  South Africa,  Ukraine, 

References & Publications (1)

Loebel A, Cucchiaro J, Silva R, Kroger H, Hsu J, Sarma K, Sachs G. Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014 Feb;171(2):160-8. doi: 10.1176/appi.ajp.2013.13 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)	Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression.; The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.; The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items.	Baseline to Week 6	No
Secondary	Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)	Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression.; The CGI depression score ranges from a minimum of 0 to a maximum of 7. For the CGI depression score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.	Baseline to Week 6	No
Secondary	Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score	Sheehan Disability Scale (SDS) total score is a subject-rated assessment of a subject's level of depression.; The SDS total score ranges from a minimum of 0 to a maximum of 30. For the SDS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.; The SDS contains three (3) items. The total score is computed as the sum of the scores for the 3 items.	Baseline to Week 6	No